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The US Food and Drug Administration (FDA) has published its proposed commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, outlining several notable departures from the current biosimilar review program. FDA said the changes are intended to streamline biosimilar application reviews and enhance regulatory efficiency.

CHARLOTTE, NC — When submitting a biologics license application (BLA), it is important to engage with the US Food and Drug Administration’s (FDA) Office of Therapeutic Products (OTP) early, make every attempt to prepare for and prevent technical and administrative errors, and keep the regulatory project manager (RPM) in the loop during the process.

The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Michael Davis, the director of the FDA's Center for Drug Evaluation and Research (CDER), stated that increasing the availability of generic versions of glucagon-like peptide-1 (GLP-1) medications is a top priority for the agency to lower costs for Americans.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, Senators grilled President Trump’s nominee to lead FDA during her confirmation hearing, and the agency published a rule to aimed at reducing animal testing.

CHARLOTTE, NC — Whether the US Food and Drug Administration (FDA) will accept clinical evidence from outside the United States (OUS) depends on if the investigations followed good clinical practice (CGP) regulations, but the data should also be applicable for regulatory purposes.

Heidi Overton, President Donald Trump’s nominee to lead the US Food and Drug Administration (FDA), faced questions from both sides of the political aisle about her views on hot-button issues facing the agency during a Senate confirmation hearing on Thursday.

Emer Cooke and other EMA leaders have weighed into the debate about whether sponsors should run one or two pivotal trials, arguing that the decision should be informed by the evidence needed to show a positive benefit-risk balance.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.